JP2007505710A - Method and apparatus for treating diseased or broken bone - Google Patents

Abstract

  The device according to the invention comprises one or more expandable structural support pylons (140), means for deploying said one or more structural support pylons (136, 141) and one or more therapeutic substances. It is good to have. The structural support pylon (20) may comprise an elastomeric core (22) or may comprise one or more suitable metals, reducing the length of the pylon and increasing its height. It is good that it is developed. Alternatively, the scaffold (200) comprises a delivery configuration in which the first unit (202) and the second unit (204) are generally connected end to end, and an upper surface (216), (218) and a lower surface (220), (222) may include a deployment configuration in which an upward force and a downward force are applied to the upper vertebral body surface and the lower vertebral body surface, respectively. The method according to the present invention comprises the steps of minimally invasive access to the interior of a diseased or damaged bone, forming a semicircular path within the bone, and one or more structural support pylons within the interior. Deploying, introducing structural reinforcement material, and optionally repeating one or more subsequent structural support pylons.

Description

  The present invention relates generally to medical devices and methods of treatment, and more particularly to devices and methods used to recover and / or repair diseased or damaged bone.

  Osteoporosis, literally “porous” bone, is a disease characterized by low bone mass and density, and structural deterioration of bone tissue. Osteoporosis results in bone weakness, increased susceptibility to fractures, including compression fractures, nerve compression, inadequate vertical support by the spine, and pain. According to the American Osteoporosis Foundation, osteoporosis is a major public health threat to an estimated 44 million Americans. According to the International Osteoporosis Foundation, osteoporosis causes over 1.5 million fractures annually, including approximately 700,000 vertebral fractures and numerous fractures in the buttocks, hips, and other areas Yes.

  Vertebral fracture is the most common fracture due to osteoporosis. About 20-25% of women over the age of 50 have one or more vertebral fractures. Once a woman has an initial vertebral fracture, the transmission of force to all vertebrae fluctuates, increasing the risk of incurring a new fracture within a year by a factor of five. Like hip fractures, vertebral fractures are associated with a significant increase in mortality in otherwise healthy older women. After such a fracture, treatments that require attachment of pins, screws, or similar devices to the vertebral body may not be feasible because the affected bone is unstable. Osteoporosis and vertebral fractures are further characterized by reduced height and frequent vertebral collapse. Such illnesses can result in stupor, diseased lung volume, nonfunctional motility, nerve compression, and pain.

  Other disease processes, including defects resulting from tumor growth, particularly round cell tumors, ischemic necrosis, and endocrine abnormalities, also result in debilitating conditions and / or fractures. These other symptoms, whether vertebrae or other sites, can also cause significant distress and reduced mobility for the patient.

  Methods for reinforcing affected and / or fractured bones and attempts to restore vertebral body height are known in the art. An example of such a method is surgery in which a medical institution guides the filling material into the bone. Such materials that are initially in a fluidized state are those that fill crevices and / or openings in the affected or damaged bone and then harden to form a hardened material that provides support to the bone. The limitation of such surgery is that the material overflows into the spine and cannot support the bone sufficiently. Currently, such filler or fusion materials are not approved for injection into the vertebral body in the United States. Therefore, there is a need for alternative and more reliable surgery.

  Accordingly, it is an object of the present invention to provide a method for stabilizing and repairing affected and / or damaged bone, whether or not it is osteoporosis. Yet another object of the present invention is to restore the vertebral body to a normal height. Yet another object of the present invention is to achieve translational compression of adjacent vertebrae and compression of nerve tissue and pain reduction. Finally, it is an object of the present invention to improve patient posture and mobility.

  Endoprostheses used for the treatment of diseased or damaged bone have an elastomeric core and reduced and expanded configurations and can withstand high multi-directional compression loads up to 6000 Newtons. The endoprosthesis may include a therapeutic substance that can be placed around the endoprosthesis via a supercritical solvent. When the endoprosthesis is in its expanded state, the endoprosthesis has a substantially ellipsoidal shape and has a higher hardness after deployment than before deployment. The hardness after deployment is in the range of 20 to 70 Shore A dumeter.

  The elastomeric core may have a through opening that may be centrally or eccentrically disposed. The endoprosthesis may be generally ellipsoidal, may have flat sides, or may be egg-shaped. The opening may include a smooth inner surface for engaging a corresponding member, or an inner surface with a screw, notch, or ratchet. The endoprosthesis may comprise a hollow interior and / or endoprosthesis member, and an end plate, or may be in the form of a braid and / or a locked braid. The endoprostheses may be used alone or in a plurality, and may be arranged offset with respect to each other. Multiple endoprostheses may be arranged as one set or as one or more individual sets.

  The endoprosthesis may comprise a plurality of folded disks and may be deployed to provide a plurality of stacked disks. The endoprosthesis includes a substantially elongated device that deploys to provide a device having upper and lower surfaces that are orthogonal to the sides, such that the height of its delivery configuration is expanded from 1.1 to 10 times. Also good. The endoprosthesis may be part of an assembly that includes an actuating arm and a structural reinforcement material.

  A method for repairing diseased or damaged bone may include transcutaneously introducing an endoprosthesis comprising a generally cylindrical or elongated delivery configuration and a generally ellipsoidal deployment configuration. The method may include forming a generally semicircular path prior to introducing the endoprosthesis. The generally semicircular path may either extend substantially parallel to the vertical axis of the spine or extend generally orthogonal. The method may include introducing a structural reinforcement material. The method may include reducing the distance between the ends of the endoprosthesis, thereby increasing the height of the endoprosthesis.

  “Vertebroplasty” is a procedure used to augment a diseased and / or fractured vertebral body, in which a biocompatible cement or filler material is large under fluoroscopy. It is injected into the vertebral body through an inner diameter needle.

  “Kyphoplasty” is an operation similar to vertebroplasty, where a balloon is used to create a space in the vertebral body before injecting biocompatible cement or filler material. Includes an additional step to restore the height of the original.

  “Spine unit” refers to a set of important functional parts of the spine including the vertebral body, endplates, facet joints, and intervertebral discs.

  The phrase “restoring bone” refers to the present invention in which a collapsed portion of diseased or damaged bone is at least temporarily restored to the substantially normal shape so that the nearly normal shape is more permanently restored. Refers to the process during treatment.

  In some embodiments according to the present invention, an apparatus called a “structural support pylon” is utilized. The structural support pylon used herein by the present invention may be of any suitable design, and the molecular weight, chemical composition, and other properties may be selected to produce the desired geometric shape. And may be made from one or more conventional alloys or shape memory alloys, polymers, or other suitable materials that have been treated and processed to achieve sterilization, the desired geometric shape and in-vivo lifetime. The structural support pylon used by the present invention may have a substantially cylindrical structure, whether it is substantially solid or hollow, or is substantially elliptical or spherical. Alternatively, a support surface may be provided at the opposite end of the expandable connecting member, and an end plate may be provided at the opposite end of the structure. Also, the structural support pylon used by the present invention preferably has a generally cylindrical structure in the delivery configuration and a structure closer to an ellipsoid than when in the deployed configuration.

  The “structural reinforcement material” used by the present invention may be substantially solid, or may be fluid in its initial state and then cured over time, or without limitation. May be cured by a number of means known in the art including exposure to an energy source as a chemical reaction or post-treatment. Suitable structural reinforcement materials include, but are not limited to, expandable polyurethane foam, polymethylmethacrylate (PMMA), catalytic reactive PMMA, calcium carbide, calcium phosphate, oxalate, polyglycolic acid, polylactic acid compounds, Does not provide polyurethane, polyethylene, shape memory polymers including high-density polyacrylamide, cyanoacrylates, hydroxyapatite derivatives, collagen, chitin, chitosan, silicon, zirconium, and structural reinforcements and / or stabilizes vertebral bodies Other materials suitable for the purpose are listed. Osteobond, available from Zimmer, Inc., Warsaw, Indiana, or Howmedica Simplex, available from Stryker Corpotation, Kalamandu, Michigan Such commercial preparations are also suitable. In any of the aforementioned materials, by adding particles comprising barium, barium sulfide, bismuth trioxide, tantalum, tungsten, zirconium, gold, platinum, platinum iridium, stainless steel, or other radiopaque material, Radiopacity can be improved.

  An “expandable” endoprosthesis has a reduced profile configuration and an expanded profile configuration. The expandable endoprosthesis according to the present invention may be able to transition from a contracted configuration to an expanded contour configuration by appropriate means or self-expansion.

  The term “fiber” refers to any generally elongated member made from any suitable material, whether polymer, metal, or metal alloy, whether natural or synthetic. Also points to.

  As used with respect to one or many fibers, the phrase “intersection” means that one fiber part or two or more fibers intersect, overlap, wrap, pass tangentially, penetrate each other, or are in close proximity or actually It refers to any points that touch each other.

  Here, if the device is left in the body for a period of time after the operation of placing the device in the body is completed, the device is referred to as “implanted”.

  The term “diffusion coefficient” refers to the rate at which a substance elutes or is passively or actively released from the substance.

  As used herein, the term “braid” refers to woven at an angle between 0 ° and 180 °, usually between 45 ° and 105 °, depending on the overall geometry and dimensions desired. One to hundreds of longitudinal and / or laterally elongated elements that can be woven, braided, knitted, spirally wound, or intertwined by any technique Refers to any braid or mesh made from or a similar woven structure.

  If not specified, suitable attachment means may include heat melting, chemical bonding, adhesives, sintering, welding, or any means known in the art.

  The term “shape memory” is a structure that defines a first form under certain physical and / or chemical conditions and can be converted to an alternative form when those conditions change. It refers to the ability of a material to perform phase change. The shape memory material may be, but is not limited to, a metal alloy or polymer that includes nickel titanium.

  A “ratchet post” is a bar that is slanted in one direction and is toothed to capture and hold a pawl or other engagement unit and prevent reverse movement.

  Without being limited, some of the embodiments according to the present invention include one or more therapeutic substances that elute from the surface. Suitable therapeutic agents include but are not limited to bone morphogenetic proteins, growth factors, osteoinductive agents and the like. In accordance with the present invention, such surface treatment and / or therapeutic substance inclusion utilizes one or more of many processes that utilize a carbon dioxide fluid, eg, liquid or carbon dioxide in a supercritical state. It is good to be done. A supercritical fluid is a substance that exceeds its critical temperature and pressure (ie, a “critical point”).

  The details of the invention will be better understood from the following description of specific embodiments according to the invention. For clarity, a spine with healthy vertebrae is shown in FIG. A healthy vertebral body 5 exhibits a normal vertebra height h. The axial load applied perpendicular to the healthy spine will be distributed between the vertebrae shown in a relatively balanced form.

  FIG. 2 shows a spine having a fractured vertebral body 10. The fractured vertebral body 10 is shown having a reduced vertebral height r. In addition to the reduced vertebra height r, the aforementioned relatively uniform axial load distribution is disturbed between the vertebrae shown. The load generated in the above-mentioned balanced form by the fractured vertebral body 10 is transmitted to the vertebral body 6 and the vertebral body 7 in the directions of the arrows 8 and 9. Furthermore, the arrangement of the vertebral bodies 6, 10 and the vertebral body 7 with respect to each other will vary in response to changes in the geometric shape of the vertebral body 10. Increased and variable loads on vertebral body 6 and vertebral body 7 increase the likelihood of fracture and / or crushing of vertebral body 6 and vertebral body 7, particularly in patients suffering from osteoporosis. Will do. The method for repairing or restoring the vertebral body 10 and the device used in such a method will be described in detail below.

  Embodiments according to the present invention suitable for use in one or more methods of the present invention are illustrated in FIGS. 3-9B and 11A-16. 3 to 5 show an embodiment according to the present invention. The structural support pylon 20 shown in the side view of FIG. 3 and the cross section of FIG. 4 further comprises an elastomer core 22 disposed between the end plates 25. The end plate 25 includes a screw element 28 extending therebetween, as shown in FIG. 3 and 4, the structural support pylon 20 is in a generally cylindrical delivery configuration having a height d and a width w. This form of delivery facilitates the minimally invasive introduction of the structural support pylon 20 to the treatment site. After delivery to the treatment site, the structural support pylon 20 advances the end plate 25 by the screw element 28, retracts the end plate 25 closer together, compresses the elastomer core 22 along the width w, Thus, the height d of the elastomer core 22 is increased, and the elastomer core 22 is arranged in a deployed form.

  As shown in FIG. 5, the structural support pylon 20 in the deployed configuration has an increased height t and a reduced deployed (or transplanted) width s. The increased height t is typically approximately between 1.1 and 8 times the height d. The structural support pylon 20 may be substantially spherical or substantially elliptical in its deployed form. Furthermore, the hardness of the structural support pylon 20 increases from a small initial hardness, such as approximately 10 Shore A durometer, to a hardness after deployment of 70 Shore due to compression axial loading. The increased hardness, in conjunction with the radial expansion described above, provides a support that can apply radial forces and withstand the spinal forces applied to the vertebral bodies. The embodiment of FIGS. 3-5 or a similar embodiment may be used alone, or two or more may be used together, as described in more detail in connection with FIGS. 13A-16. Also good.

  6A and 6B show an embodiment similar to the embodiment of FIGS. The structural support pylon 30 includes an elastomeric core 32, an end plate 35, a delivery configuration height h, and a delivery configuration width w. By retracting the end plates 35 closer together, the configuration of the structural support pylon 30 is adapted to transition from its delivery configuration shown in FIG. 6A to its deployed configuration shown in FIG. 6B. In its deployed configuration, the structural support pylon 30 has an increased deployed configuration height t and a decreased deployed configuration width s. When the structural support pylon 30 is in its deployed configuration, it may have either a shape that is closer to a substantially ellipsoid or a shape of a substantially sphere.

  In order to maintain its deployed configuration, the structural support pylon 30 includes a ratchet post 36 extending between the end plates 35, as shown in the cross section of FIG. The ratchet column 36 includes a ratchet handle 37, a ratchet bar 38, and a plurality of teeth 39. When the ratchet bar 38 is advanced by the ratchet handle 37, the teeth 39 are engaged with the ratchet column engaging member 34, so that the end plates 35 are irreversibly pulled close to each other.

  8A-8C illustrate yet another embodiment of an apparatus suitable for use with the present invention. FIG. 8A is a side view of the structural support pylon 40 in a generally cylindrical delivery configuration comprising a pylon member 41, a slot 42, an end 43, and a threaded hole 44. As shown in FIG. 8B, the pylon member 41 includes a tapered region 45 adjacent to the end portion 43. As a result, the tapered region 45 constitutes a selective bending region 46. In order to deploy the structural support pylon 40, an actuation tool (not shown) is introduced through and engaged with the screw hole 44, and the ends 43 are close to each other in the direction of arrow 47. It is supposed to be pulled in. On the other hand, the pylon member 41 is bent in the selective bending region 46, and the structural support pylon 40 is converted from a substantially cylindrical shape to a substantially ellipsoidal shape between the end portions 43.

  The embodiment shown in FIG. 8D is similar to the embodiment shown in FIG. 8C. The structural support pylon 48 includes a selective bending region 49 of the pylon member 51, thereby facilitating the transition to the illustrated deployed configuration.

  Alternatively, according to the present invention, an inverted sleeve device as shown in FIGS. 9A and 9B may be used. The structural support sleeve 50, shown in FIG. 9A in a generally cylindrical delivery configuration, has an inverted end 52. End 52 includes a threaded arm 54 shown in the cross-section of FIG. 9A and engages sleeve 50 therein. An actuating tool (not shown) may be used to advance the threaded arm 54, thereby tightening the ring 53 in the direction of arrow 55. By tightening the sleeve 53 in the direction of the arrow 55, the sleeve 53 is expanded in the direction of the arrow 56. As with the previous embodiment, the structural support sleeve 50 is correspondingly adapted to transition from its delivery configuration to its deployed configuration. The foregoing embodiments typically have their height increased by 1.1 to 8 times during deployment.

  Alternatively, a substantially cylindrical structural support pylon with an open end may be used in the method according to the invention. In this case, the substantially cylindrical structural support pylon may be expanded by mechanical means, for example, as shown in FIGS. 10A and 10B. As shown in the example of FIGS. 10A and 10B, the structural support pylon 82 shown in cross-section may gradually taper the plug 83 into the structural support pylon 82, or else the structural support pylon. It may be expanded by retracting 82 around the tapered plug 83. Such a device may be used alone or may be used in conjunction with two or more devices by the method according to the invention.

  Referring to FIGS. 11A-11C, a method of treatment and alternative embodiments according to the present invention are shown. FIG. 11A is a side view of the collapsed vertebral body 90. A soft and steerable trocar 95 is introduced into the collapsed vertebral body 90 in a minimally invasive manner. A flexible steerable trocar 95 is attached to a flexible cable that is steerable 360 ° and is introduced from the rear, initially in the direction of the lower vertebral endplate 94 and then toward the upper vertebral endplate 92. It is good to turn.

  Thus, the flexible and steerable trocar 95 forms a substantially curved path that defines a semicircle substantially parallel to the vertical plane as seen in the side views of FIGS. An alternative path according to an alternative embodiment according to the invention is shown in FIGS. 13A and 13B below). A flexible drill or curved obturator or cone (not shown) is percutaneously removed to remove the fractured bone material in the collapsed vertebral body 90 along the path established by the flexible and steerable trocar 95. Should be introduced.

  As shown in FIG. 11B, after the aforementioned pathway is formed, a flexible cannula 97 that supports the vertebral body jack 100 (in the delivery configuration) may be introduced into the collapsed vertebral body 90. Once the flexible cannula 97 is in the desired position, the vertebral body jack 100 is pushed out of the distal end of the flexible cannula 97 by actuating a push mandrel (not shown) within the cannula 97. When ejected from inside the flexible cannula 97, the vertebral body jack 100 transitions to its deployed configuration, as shown in FIG. 11C. When the vertebral body jack 100 is converted to its deployed configuration, the prosthetic upper plate 105 applies a force against the upper vertebral endplate 92. At the same time, the prosthetic lower end plate 106 applies an outwardly directed force to support the inferior vertebral body endplate 94, thereby providing a large normal force, substantially vertebral body 90, as shown in FIG. Stabilize and / or restore vertebral plate to normal height.

  The jack support member 102 includes a threaded connection member 104 that may be actuated by a drive mechanism within the cannula 97. Alternatively, the jack support member 102 may be made from a conventional shape memory material that is conditioned to return to the deployed configuration when delivered from the distal end of the cannula 97 and to exhibit a large vertical support configuration. Good. As yet another alternative, the jack support member 102 may include a ratcheted connection member that is actuated by a tool in the cannula to deploy the jack support member 102.

  Referring to FIG. 12, an alternative embodiment according to the present invention is shown in a deployed configuration within the vertebral body. The basket 125 is delivered and deployed according to any of the delivery paths described above in connection with FIGS. 11A-11C, or alternatively, the delivery paths described below in connection with FIGS. 13A and 13B. ing. The basket 125 comprises a concentric ring 127 and a generally spherical, ellipsoidal, annular or other suitable form. Basket 125 may be covered with a biocompatible elastomer film and / or may be filled with a biocompatible polymer or other suitable structural support material. The basket 125 applies an outward force to the upper vertebral body endplate 122 and the lower vertebral body endplate 123 in multiple directions, particularly in the vertical direction. In the embodiment shown in FIGS. 11C and 12, in most cases the height is increased 1.1 to 10 times the height in the delivery configuration.

  As described above, the embodiments of FIGS. 3-5 can be used alone or in multiple sets. FIG. 13A illustrates an alternative method in accordance with the present invention in which multiple structural support members 140 may be used. FIG. 13A is a top view of the vertebral body 130. According to the method shown in FIGS. 13A and 13B, a flexible and steerable trocar (not shown) is minimally invasively introduced from the posterior, and the interior of the vertebral body 130 is orthogonal to the substantially vertical axis of the spinal column. The vertebral body 130 is guided substantially laterally along the anterior curve of the vertebral body 130. With a flexible and steerable trocar, a path through the interior of the vertebral body 130 is percutaneously formed, and then an obturator or cone (not shown) is optionally used to affect and / or damage It is good to remove the damaged bone.

  As shown in FIG. 13A, a flexible and steerable cannula 135 for delivery of a plurality of structural support pylons 140 is introduced along an appropriate path formed as described above. When the flexible and steerable cannula 135 is placed in the desired location within the vertebral body 130, the structural support pylon 140 is advanced to the mandrel stop 136. An extrusion tube (not shown) pushes the washer 141 against the structural support pylon 140 and attaches to it. The force applied to the structural support pylon 140 reduces the length of the pylon 140, widens its circumference and increases hardness. This hardness increases from a small initial hardness, such as approximately 10 Shore A durometer, to a hardness after development of 70 Shore A, depending on the compression axial load. The structural support pylon 140 can be expanded radially to apply a radial force and provide a support that can withstand the spinal force applied to the vertebral body.

  Furthermore, the structural support pylon 140 transitions from a generally cylindrical configuration to a generally ellipsoidal or generally circular configuration (such transition is as described above for the individual structural support pylons in FIGS. 3-8. Is). This featured form and simple deployment allows the pylon to be delivered non-invasively and then provide sufficient support form within the affected and / or damaged vertebral body. The above procedure is repeated for each subsequent washer 141 and structural support pylon 140. A plurality of deployed structural support pylons 140 (washer 141 not visible) and a final washer 137 are shown in FIG. 13B.

  For clarity, FIG. 13C is an exploded view of alternating structural support pylon 140 and washer 141. As shown in FIG. 13D, when actually deployed on the mandrel 138, the washer 141 cannot be seen sandwiched between each structural support pylon 140. Similarly, FIG. 13E demonstrates the pre-deployment and post-deployment configurations of the structural support pylon and the staggered washer positions. The structural support pylon 142 is compressed and deployed with alternating washers 143. The structural support pylon 144 has not yet been deployed. This structural support pylon 144 will advance further over the mandrel 145 and abut against each washer 143. The proximal washer 143 will then advance over the mandrel 145, reducing the distance between each washer 143 and compressing the structural support pylon 144 until the deployed configuration of the structural support pylon 144 is achieved. .

  The structural support pylon 140 may be made from a suitable polymeric material. Optionally, the structural support pylon 140 may include a polymeric material that exhibits strain-induced crystallization, thereby further increasing the hardness of the material when compressed. Suitable materials may also be polymeric composites, silicones, rubbers, metals, and other natural and synthetic materials.

  In an alternative to the method shown in FIGS. 13A and 13B, one or more structural support pylons may be introduced into the vertebral body from two separate entry points. One or more structural support pylons are introduced from the first entry point shown in FIG. 13A and are introduced from corresponding entry points on the opposite side of the vertebral body in subsequent steps, thereby being placed opposite one another. You can also make it.

  According to the present invention, the plurality of structural support pylons may have alternative forms. For example, the structural support pylon 150, shown alone in the end view of FIG. 14A, includes a generally central opening 155. When attached to the mandrel 157, the multiple structural support pylons 150 may be offset from each other at an angle between 45 ° and 90 °, as shown in the end view of FIG. 14B. FIG. 14C shows the appearance of such a form after deployment. Since each structural support pylon 150 is offset relative to each adjacent structural support pylon, it can exhibit greater expansion in a given direction, resulting in a larger diameter device overall. As in the previous embodiment, the hardness of the structural support pylon increases when deployed.

  Alternative configurations are also shown in FIGS. 15A-15C. A structural support pylon 160 with an eccentric opening 165 is shown alone in the end view of FIG. 15A. The plurality of structural support pylons 160 may be attached to the mandrel 167 at an angle between 45 ° and 90 °, as shown in the end view of FIG. 15B. Because the individual structural support pylons 160 are offset from each other, each pylon can expand more greatly in a given direction, resulting in a larger diameter prosthesis overall, as shown in FIG. 15C. Will be. As in the previous embodiment, the hardness of the structural support pylon will increase upon deployment.

  16A-16C illustrate the above-described principles for yet another alternative embodiment, the structural support pylon 170. FIG. FIG. 16A is an end view showing a substantially egg shape and a substantially central opening 175 before deployment. The deployed configuration of the plurality of structural support pylons 170 when mounted offset from each other at an angle between 45 ° and 90 ° is shown in the side view of FIG. 16C. As described above in connection with FIGS. 14A-14C, greater expansion rates can be achieved overall by shifting the individual support pylons. Therefore, an expansion rate in the range of 1.1 times to 8 times can be achieved.

  Suitable materials for the structural support pylon include, but are not limited to, biocompatible metals, alloys including nickel titanium, polymers, ceramics, and composites thereof.

  FIG. 17 is a side view of another alternative embodiment according to the present invention. The embodiment of FIG. 17 includes a plurality of structural support disks 180. These discs 180 are arranged substantially adjacent to each other when deployed. The delivery configuration of such an embodiment comprises a separate disk mounted within the delivery cannula 187, with each disk folded into a conical or other suitable shape within the delivery cannula 187. After the delivery path is formed in the vertebral body according to any of the previous embodiments, the delivery cannula 187 is placed at the desired location and a push mandrel (not shown) attaches the structural support disk 180 to the delivery cannula 187. Each one is discharged from the end. The structural support disk returns from the folded delivery configuration to the deployed configuration, thereby providing multiple support points at desired locations within the affected and / or damaged vertebral body. Typically, the height of the aforementioned embodiment can be increased from 1.1 to 10 times the height of the delivery form.

  Suitable materials for the structural support disk include, but are not limited to, biocompatible metals, alloys including nickel titanium, polymers, ceramics, and composites thereof.

  18A-18E illustrate a structural support pylon 190, which is yet another alternative embodiment. The structural support pylon 190, whose delivery configuration is shown in FIG. 18A, comprises an “inverted” layered braided structure. The first layer 192 of the structural support pylon 190 is pushed out of the distal end of the delivery cannula 197 after a generally semicircular or other suitable form of path is formed in the vertebral body by any of the methods previously described. . The structural support pylon fibers 193 may be made of any suitable material and may include shape memory properties. 18A and 18B show the first layer 192. FIG. Then, to continue deployment of the structural support pylon 190, additional fibers 193 as shown in the partial cross section of FIGS. 18C and 18D (the first layer 192 is omitted in these views). Is pushed from the distal end of the cannula 197 to form a second layer 194 in the structural support pylon 190. This process may be repeated to form a third layer 196 as shown in FIG. 18E. The lock 198 is then engaged to secure the fiber 193 in the deployed configuration. This causes the structural support pylon 190 to provide continuous support within the affected and / or damaged vertebral body. Alternatively, a braid design that is not reversely arranged may be used.

  FIG. 19A shows an alternative embodiment according to the present invention in an elongated delivery configuration. The skeleton 200 may alternatively include a single unit, but here includes a first unit 202 and a second unit 204. The scaffold 200 may be delivered by a method similar to that described in connection with FIGS. 11A-11C or a method similar to that described in connection with FIGS. 13A-13C. Alternatively, the skeleton 200 may be delivered percutaneously alone, from a curved or non-curved posterior passageway, or subsequently, a second pylon (not shown) may be For example, it may be delivered transdermally on the opposite side. The scaffold 200 may be delivered, for example, via a cannula.

  In the delivery form, the first unit 202 and the second unit 204 are in a form of end-to-end connection. The first end plate 206, the second end plate 208 and the third end plate 210 are in communication with the first unit 202 and the second unit 204. The interior 212 of the first actuator wheel 206, as well as the interior of the second and third wheels, is smoothed or threaded, notched or otherwise machined, correspondingly smoothed or screwed, It is good to engage with an actuator arm (not shown) to which a notch or other processing is applied. Once engaged, the actuator arm is actuated to convert the skeleton 200 from its delivery configuration to the deployed configuration shown in FIG. 19B.

  The skeleton 200 includes upper surfaces 216 and 218 and lower surfaces 220 and 222. The skeleton 200 further comprises side surfaces 224, 225, 226 and 227 made from portions 224a, 224b, 225a, 225b, 226a, 226b, 227a and 227b. When the scaffold 200 is in its delivery configuration, the portion 224a of the side 224 is generally located end to end connected by the top surface 216, and the portion 224b of the side 224 is generally end to end by the bottom surface 220. Are connected. Similarly, the portion 225a of the side surface 225 is positioned so that the upper surface 216 is generally connected to the end and the end, and the portion 225b of the side surface 225 is approximately positioned to be connected to the lower surface 220 and the end and end. In the corresponding second unit 204, the portion 226 a of the side surface 226 is located approximately end-to-end with the upper surface 218, and the end 226 b of the side surface 226 is approximately end-to-end connected with the lower surface 222. positioned.

  After deployment via an actuator arm (not shown), the skeleton configuration is converted to the deployment configuration shown in FIG. 19B. In its deployed configuration, the side surfaces 224, 225, 226, and 227 are positioned substantially perpendicular to the upper surfaces 216, 218 and the lower surfaces 220, 222. Before conversion, the skeleton 220, which has only a height d approximately equal to the height of the actuator wheels 206, 208 and 210, has a height h at this point. The height h is typically between 1.1 and 10 times the height d.

  Furthermore, when deployed in a vertebral body (not shown), the upper surfaces 216, 218 apply an upward force to the bottom surface of the upper vertebral body endplate and the lower surfaces 220, 222 apply the upper surface of the lower vertebral body endplate. This supports and stabilizes the vertebral body and restores the vertebral body to a normal height.

  20A and 20B show another modification of the above-described embodiment. FIG. 20A shows a skeleton 400 attached to a delivery mandrel 401. After deployment, the skeleton 400 comprises the configuration shown in FIG. 20B. In the expanded form, the side portions 424a, 424b, 425a, 425b, 426a, 426b, 427a, 427b are positioned substantially perpendicular to the upper surfaces 416, 418 and the lower surfaces 420, 422.

  Prior to deployment, the skeleton 400, which has only a height d approximately equal to the height of the end plate 406, has a height h at this point. The height h is typically between 1.1 and 10 times the height d. Further, as in the previous embodiment, when the skeleton 400 is deployed in a vertebral body (not shown), the upper surfaces 416, 418 apply an upward force to the bottom surface of the upper vertebral body endplate and the lower surfaces 420, 422 Supports the upper surface of the lower vertebral body endplate, thereby reinforcing and stabilizing the vertebral body and restoring the vertebral body to a normal height. Furthermore, the pin 403 in the delivery configuration of FIG. 20A protrudes in the deployed configuration of FIG. 20B. In the deployed configuration, the pins 403 project to engage the interior of the vertebral body or the vertebral body and endplate, and act to anchor the skeleton 400 within the vertebral body.

  FIG. 20C shows a similar embodiment according to the present invention in a deployed configuration. The anchoring member 503 protrudes from the upper surfaces 516 and 518 and the lower surfaces 520 and 522. Instead of pins or anchors, the upper and lower surfaces of the device may be provided with surface roughness, barbs, adhesive, or other suitable means for securing the device within the vertebral body. Any of the foregoing embodiments according to the present invention can typically withstand compressive stresses of over 700 to 1,000 Newtons and withstand cyclic loads of over 500-1200 Newtons over 10 million cycles. . The embodiments described above in FIGS. 19A-20C may be made from stainless steel, titanium, nickel titanium, or other suitable material.

  While particular forms of the invention have been illustrated and described, the foregoing description is intended to be illustrative only and various modifications can be made by those skilled in the art without departing from the spirit and scope of the invention. It will be clear. For example, the foregoing description has described an example of treating a vertebral body because of the high incidence and severity of damage to the vertebral body, the concept of the present invention here is the spirit and scope of the present invention. It will be apparent that it can be applied to other affected and / or injured sites without departing from the above.

It is a perspective view of the spine of a healthy person. It is a perspective view of the part of the spine of the person whose vertebral body was crushed. FIG. 6 is a side view of an embodiment of the present invention in a delivery configuration. FIG. 4 is a side sectional view of the embodiment of FIG. 3. FIG. 4 is a side view of the embodiment of FIG. 3 after deployment. FIG. 6 is a side view of an alternative embodiment according to the present invention in a delivery configuration. FIG. 6 is a side view of an alternative embodiment according to the present invention in a deployed configuration. FIG. 6 is a side cross-sectional view of an alternative embodiment according to the present invention. FIG. 6 is a side view of yet another embodiment according to the present invention in a delivery configuration. It is sectional drawing of the member of embodiment of FIG. 8A. FIG. 8B illustrates the embodiment of FIG. 8A in an expanded configuration. FIG. 7 shows the structure of yet another alternative embodiment of a device suitable for use with the present invention in an expanded configuration. FIG. 6 illustrates the structure and sequence of deployment steps of another alternative embodiment of an apparatus suitable for use with the present invention. FIG. 6 illustrates the structure and sequence of deployment steps of another alternative embodiment of an apparatus suitable for use with the present invention. FIG. 4 is a side view showing the steps of deploying the device according to the present invention and the series of devices associated therewith. FIG. 4 is a side view showing the steps of deploying the device according to the present invention and the series of devices associated therewith. FIG. 3 is a side view showing a vertebral body through which a series of steps of treatment according to the present invention are made and a sequence of steps for deploying a device according to the present invention. FIG. 3 is a side view showing a vertebral body through which a series of steps of treatment according to the present invention are made and a sequence of steps for deploying a device according to the present invention. FIG. 3 is a side view showing a vertebral body through which a series of steps of treatment according to the present invention are made and a sequence of steps for deploying a device according to the present invention. FIG. 6 shows an alternative embodiment according to the present invention. FIG. 6 shows a sequence of steps of an alternative method and development of an alternative embodiment according to the present invention. FIG. 6 shows a sequence of steps of an alternative method and development of an alternative embodiment according to the present invention. FIG. 14 is a supplementary depiction of the embodiment shown in FIGS. 13A and 13B. FIG. 14 is a supplementary depiction of the embodiment shown in FIGS. 13A and 13B. FIG. 14 shows an embodiment similar to that shown in FIGS. 13A and 13B with a supplementary depiction. FIG. 6 is a side view of an alternative embodiment according to the present invention in a deployed configuration. FIG. 14B is an end view of the elements used to make the embodiment of FIG. 14A. FIG. 14B is an end view of the elements used to make the embodiment of FIG. 14A. FIG. 6 is a side view of an alternative embodiment according to the present invention in a deployed configuration. FIG. 15B is an end view of the elements used to make the embodiment of FIG. 15A. FIG. 15B is an end view of the elements used to make the embodiment of FIG. 15A. FIG. 6 is a side view of an alternative embodiment according to the present invention in a deployed configuration. FIG. 16B is an end view of the elements used to make the embodiment of FIG. 16A. FIG. 16B is an end view of the elements used to make the embodiment of FIG. 16A. FIG. 7 shows yet another alternative embodiment according to the present invention. FIG. 6 is a side view showing yet another alternative embodiment of the present invention and a series of associated deployment steps. FIG. 6 is a side view showing yet another alternative embodiment of the present invention and a series of associated deployment steps. FIG. 6 is a side view showing yet another alternative embodiment of the present invention and a series of associated deployment steps. FIG. 6 is a side view showing yet another alternative embodiment of the present invention and a series of associated deployment steps. FIG. 6 is a side view showing yet another alternative embodiment of the present invention and a series of associated deployment steps. FIG. 6 is a perspective view of yet another alternative embodiment according to the present invention in a delivery configuration. FIG. 6 is a perspective view of yet another alternative embodiment according to the present invention in a deployed configuration. FIG. 6 shows yet another embodiment according to the present invention attached to a mandle in a delivery configuration. FIG. 6 is a view showing still another embodiment according to the present invention attached to a mandle in an unfolded configuration. FIG. 6 shows an alternative embodiment according to the present invention in an expanded configuration.

Claims (78)

  An endoprosthesis used for the treatment of diseased or broken bone, comprising an elastomer core, a reduced diameter form and an enlarged form.   The endoprosthesis according to claim 1, characterized in that it has a radially outward strength sufficient to withstand a multidirectional load, said multidirectional load comprising a compressive load between 50N and 6000N. organ.   The endoprosthesis according to claim 1, further comprising one or more therapeutic substances.   4. The endoprosthesis of claim 3, wherein the one or more therapeutic substances include a bone morphogenic protein.   The endoprosthesis of claim 3, wherein the one or more therapeutic substances are disposed around the endoprosthesis using a solvent in a supercritical state.   The endoprosthesis according to claim 1, wherein the diameter-reducing form includes a substantially cylindrical form, and the diameter-expanding form includes a substantially ellipsoidal shape or a substantially spherical shape.   The elastomer core has a first hardness when the endoprosthesis is in the reduced diameter configuration, has a second hardness when the endoprosthesis is in the expanded configuration, and the second hardness is The endoprosthesis of claim 1, wherein the endoprosthesis is greater than the first hardness.   8. The endoprosthesis of claim 7, wherein the first hardness is in the range of less than 10 Shore A durometer and the second hardness is in the range of 20 to 70 Shore A durometer.   The endoprosthesis according to claim 1, wherein the elastomeric core has an opening therethrough.   The endoprosthesis according to claim 9, wherein the opening is located centrally within the elastomeric core.   The endoprosthesis according to claim 9, wherein the opening is arranged eccentrically in the elastomer core.   7. An endoprosthesis according to claim 6, wherein the generally cylindrical form comprises one or more flat sides.   The endoprosthesis according to claim 6, wherein the substantially cylindrical form includes a horizontal axis and a substantially egg-shaped cross section along the horizontal axis.   The endoprosthesis of claim 9, wherein the opening comprises a threaded inner surface for engaging a screw member.   The endoprosthesis of claim 9, wherein the opening comprises an inner surface with a notch for engaging a ratchet member.   10. An endoprosthesis according to claim 9, wherein the opening comprises a smooth surface for engaging a smooth mandle.   The endoprosthesis according to claim 1, characterized in that the enlarged form is 1.1 to 10 times larger than the reduced form.   An endoprosthesis used to repair a diseased or fractured bone, comprising an endoprosthesis member, a substantially hollow interior, an end plate, and a reduced diameter and expanded diameter form An endoprosthesis characterized by   19. An endoprosthesis according to claim 18, characterized in that it has a radially outward strength sufficient to withstand a multidirectional load, said multidirectional load comprising a compressive load between 50N and 6000N. organ.   19. An endoprosthesis according to claim 18, further comprising one or more therapeutic substances.   21. The endoprosthesis of claim 20, wherein the one or more therapeutic substances include bone morphogenic proteins.   21. The endoprosthesis according to claim 20, wherein the one or more therapeutic substances are disposed around the endoprosthesis using a solvent in a supercritical state.   19. An endoprosthesis according to claim 18, wherein the end plate comprises a threaded inner surface for engaging a screw element.   The endoprosthesis of claim 18, wherein the end plate has an inner surface with a notch for engaging a ratchet member.   The endoprosthesis according to claim 18, wherein the end plate comprises a smooth surface for engaging a smooth mandrel.   The endoprosthesis according to claim 18, wherein the endoprosthesis member comprises a selective bending region.   The endoprosthesis according to claim 18, wherein the reduced diameter form is a substantially cylindrical shape, and the enlarged diameter form is a substantially ellipsoid or a substantially spherical body.   A center region and one or more end regions, wherein the diameter expansion form is a substantially ellipsoid or a sphere centered on the center region, and a substantially cylinder centered on the one or more end regions. The endoprosthesis according to claim 18, characterized in that   The endoprosthesis according to claim 18, characterized in that the enlarged form is 1.1 to 10 times larger than the reduced form.   An endoprosthesis used to repair a diseased or fractured bone comprising a sleeve, one or more inverted end members, and an interior, the one or more inverted end members comprising: An endoprosthesis that engages with the sleeve in the interior, the endoprosthesis having a reduced profile configuration and an expanded profile configuration.   31. The endoprosthesis of claim 30, wherein the inverted end member has a threaded inner surface for engaging a screw member.   An endoprosthesis used to repair a diseased or fractured bone, the endoprosthesis comprising a reduced profile delivery configuration and an expanded profile deployment configuration, wherein an upper end plate, a lower end plate, and An endoprosthesis comprising an expandable member disposed therebetween.   33. The endoprosthesis of claim 32, wherein the expandable member comprises a screw element.   34. The endoprosthesis of claim 33, wherein the expandable member comprises a ratchet element.   34. The endoprosthesis of claim 33, wherein the expandable member is self-expanding.   An assembly for use in repairing a diseased or fractured bone, the assembly comprising a plurality of structural support pylons.   37. The assembly of claim 36, further comprising a structural reinforcement material.   37. The assembly of claim 36, further comprising a screw element, wherein the plurality of structural support pylons are adapted to be engaged with the screw element.   37. The assembly of claim 36, further comprising a ratchet element, wherein the plurality of structural support pylons are adapted to be engaged with the ratchet element.   40. The assembly of claim 36, further comprising a smooth mandrel, wherein the plurality of structural support pylons are adapted to engage the mandrel.   37. The one or more of the plurality of structural support pylons, wherein the one or more structural support pylons are disposed at an angle between 45 ° and 90 ° relative to an adjacent structural support pylon. Assembly.   An assembly for use in repairing a diseased or fractured bone comprising a plurality of structural support disks and having a reduced profile delivery configuration and an expanded profile deployment configuration .   Endoprosthesis used to repair diseased or fractured bone, characterized in that it has a reduced profile delivery configuration and an expanded profile deployment configuration and has an inverted layered braid configuration .   44. Endoprosthesis according to claim 43, characterized in that it comprises means for locking the braided form.   An endoprosthesis for use in the treatment of diseased or fractured bone, comprising a delivery configuration and a deployment configuration, wherein the delivery configuration is generally cylindrical and the deployment configuration is generally ellipsoid.   46. Endoprosthesis according to claim 45, characterized in that it is adapted to be deployed by mechanical means.   The endoprosthesis according to claim 46, characterized in that the mechanical means comprises a ratchet column.   49. Endoprosthesis according to claim 46, characterized in that it comprises an end plate and the mechanical means comprises a screw element connecting the end plate.   The endoprosthesis of claim 46, wherein the screw element is disposed within the endoprosthesis.   In an endoprosthesis used to treat a diseased or fractured bone, the endoprosthesis comprises a delivery configuration and a deployment configuration, the delivery configuration comprising a first width and a first height, the deployment configuration comprising a second reduced width and a first configuration. 2. An endoprosthesis characterized by having an increased height.   51. The endoprosthesis of claim 50, wherein the second increased height is between 1.1 and 10 times the first height.   51. The endoprosthesis of claim 50, comprising a plurality of folded discs when in the delivery configuration and a plurality of expanded discs when in the deployed configuration.   An upper surface, a lower surface, and two or more side portions, wherein in the delivery configuration, one or more of the side portions are located in substantially the same plane as the upper surface, and One or more are located in a plane substantially the same as the lower surface, and when in its deployed configuration, one or more of the side portions are in a plane substantially perpendicular to the upper surface and the side 51. The endoprosthesis of claim 50, wherein one or more of the portions are in a plane that is substantially perpendicular to the lower surface.   54. The endoprosthesis according to claim 53, wherein one or more of the upper and lower surfaces comprises means for engaging the interior of a vertebral body.   55. The endoprosthesis of claim 54, wherein the means comprises a rough surface.   55. The endoprosthesis of claim 54, wherein the means comprises one or more protrusions.   55. Endoprosthesis according to claim 54, characterized in that said means comprise one or more adhesives.   55. Endoprosthesis according to claim 54, characterized in that said means comprise chemical means.   55. The endoprosthesis of claim 54, wherein the means comprises one or more barbs.   An assembly used to repair a diseased or fractured bone, comprising one or more structural support pylons and an actuating arm for deploying the one or more structural support pylons. Assembly.   61. The assembly of claim 60, further comprising a structural reinforcement material.   61. The assembly of claim 60, wherein the operating arm is smooth.   61. The assembly of claim 60, wherein the actuating arm is adapted to be screwed.   61. The assembly of claim 60, wherein the actuating arm is ratchet driven.   61. The assembly of claim 60, further comprising one or more washers. In a minimally invasive method for repairing diseased or broken bones,
Percutaneously introducing an endoprosthesis into the damaged bone, the endoprosthesis comprising a generally cylindrical delivery configuration and a generally elliptical or generally spherical deployment configuration;
A minimally invasive method comprising:   68. The method of claim 66, wherein the generally semicircular path is formed in the bone prior to introducing the endoprosthesis.   68. The method of claim 67, wherein the generally semicircular path is oriented vertically within the bone.   68. The method of claim 67, wherein the generally semicircular path is oriented laterally within the bone.   67. The endoprosthesis is generally cylindrical, includes an interior, and deploying the generally cylindrical endoprosthesis includes pulling a tapered plug into the interior. The method described in 1.   68. The method of claim 66, further comprising administering a therapeutic agent into the affected or fractured bone.   68. The method of claim 66, further comprising introducing a structural support material into the affected or damaged bone.   The endoprosthesis includes first and second ends, the first and second ends being spaced apart by a first distance when the endoprosthesis is in its delivery configuration, and the endoprosthesis is deployed thereof. 68. The method of claim 66, wherein when in a configuration, the step of deploying the endoprosthesis spaced apart by a shorter second distance comprises reducing the first distance.   The endoprosthesis comprises a number of endoprosthesis members and gaps therebetween, wherein the endoprosthesis member comprises one or more selective bending regions. 66. The method according to 66.   The endoprosthesis includes a screw element that engages the first and second ends, and the step of reducing the first distance includes placing one of the first and second ends over the screw element. 75. The method of claim 74, comprising advancing.   76. The method of claim 75, wherein the endoprosthesis comprises an interior and the screw element is disposed within the interior.   75. The method of claim 74, wherein the endoprosthesis comprises a ratchet column and the step of reducing the first and second distances includes actuating the ratchet column.   The endoprosthesis includes a smooth mandrel that engages the first and second ends, and the step of reducing the first distance advances the first and second ends over the smooth mandrel. 75. The method of claim 74, comprising steps.

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